US2009054305A1PendingUtilityA1

Mixtures of Amylin and Insulin

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Assignee: NOVO NORDISK ASPriority: Mar 15, 2006Filed: Mar 15, 2007Published: Feb 26, 2009
Est. expiryMar 15, 2026(expired)· nominal 20-yr term from priority
Inventors:Morten SchleinThomas Kruse HansenJesper LauSvend Ludvigsen
A61P 43/00A61K 38/22A61P 3/10A61K 9/0019A61K 38/28A61P 3/00
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Claims

Abstract

The present invention relates to a soluble pharmaceutical composition for parenteral administration, which comprises an amylin peptide, and a meal-related insulin peptide, and to the use of such compositions for treatment of e.g. hyperglycemia.

Claims

exact text as granted — not AI-modified
1 . A soluble pharmaceutical composition for parenteral administration, which comprises an amylin peptide, and a meal-related insulin peptide. 
     
     
         2 . The pharmaceutical composition according to  claim 1 , wherein the pH of said pharmaceutical composition or a reconstituted solution of said pharmaceutical composition is from about pH 6.5 to about pH 9.0. 
     
     
         3 . The pharmaceutical composition according to  claim 1 , wherein said meal-related insulin peptide is human insulin, an analog of human insulin, a derivative of human insulin or a derivative of a human insulin analog. 
     
     
         4 . The pharmaceutical composition according to  claim 3 , wherein said meal-related human insulin analog is human insulin B28D . 
     
     
         5 . The pharmaceutical composition according to  claim 3 , wherein said meal-related human insulin analog is human insulin B3K, B29E . 
     
     
         6 . The pharmaceutical composition according to  claim 3 , wherein said meal-related human insulin analog is human insulin B28K, B29P . 
     
     
         7 . The pharmaceutical composition according to  claim 1 , wherein the concentration of said meal-related insulin peptide is in the range from about 1.2 mg/mL to about 5.6 mg/mL. 
     
     
         8 . The pharmaceutical composition according to  claim 1 , wherein said amylin peptide is amylin, an amylin analog or an amylin agonist. 
     
     
         9 . The pharmaceutical composition according to  claim 1 , wherein said amylin peptide is  25, 28, 29 Pro-h-amylin. 
     
     
         10 . The pharmaceutical composition according to  claim 1 , wherein said amylin peptide is human amylin methylated in position 24 and 26. 
     
     
         11 . The pharmaceutical composition according to  claim 1 , wherein said insulin peptide is human insulin B28D  and said amylin peptide is  25, 28, 29 Pro-h-amylin. 
     
     
         12 . The pharmaceutical composition according to  claim 1 , wherein said insulin peptide is human insulin B3K,B29E  and said amylin peptide is  25, 28, 29 Pro-h-amylin. 
     
     
         13 . The pharmaceutical composition according to  claim 1 , wherein said insulin peptide is human insulin B28K, B29P  and said amylin peptide is  25, 28, 29 Pro-h-amylin. 
     
     
         14 . The pharmaceutical composition according to  claim 1 , wherein the pH of the said pharmaceutical composition or a reconstituted solution of said pharmaceutical composition is from about pH 2.5 to about pH4.5. 
     
     
         15 . The pharmaceutical composition according to  claim 1 , wherein said meal-related human insulin analog is insulin A21G, B28D, des B30 . 
     
     
         16 . The pharmaceutical composition according to  claim 1 , wherein said meal-related human insulin analog is insulin A21G, B28E, des B30 . 
     
     
         17 . The pharmaceutical composition according to  claim 1 , comprising zinc and/or calcium. 
     
     
         18 . The pharmaceutical composition according to  claim 1 , wherein said pharmaceutical composition comprises a preservative. 
     
     
         19 . The pharmaceutical composition according to  claim 1 , wherein said pharmaceutical composition comprises a buffer. 
     
     
         20 . The pharmaceutical composition according to  claim 1 , wherein said pharmaceutical composition comprises an isotonicity agent. 
     
     
         21 . The pharmaceutical composition according to  claim 1 , which further comprises a stabiliser. 
     
     
         22 . The pharmaceutical composition according to  claim 1 , which further comprises a surfactant. 
     
     
         23 . The pharmaceutical composition according to  claim 22 , wherein said surfactant is anionic. 
     
     
         24 . The pharmaceutical composition according to  claim 23 , wherein said anionic surfactant is a glycerophosphoglycerol derivative. 
     
     
         25 . The pharmaceutical composition according to  claim 24 , wherein said glycerophosphoglycerol derivative is a dimyristoyl derivative. 
     
     
         26 . The pharmaceutical composition according to  claim 24 , wherein said said glycerophosphoglycerol derivative is 1,2-Dimyristoyl-sn-glycero-3-phospho-rac-(1-glycerol) (DMPG). 
     
     
         27 . The pharmaceutical composition according to  claim 1 , wherein the surfactant is added in a concentration between 0.1 mM and 10 mM. 
     
     
         28 . (canceled) 
     
     
         29 . A method for treatment of hyperglycemia comprising parenteral administration of an effective amount of the pharmaceutical composition comprising an amylin peptide, and a meal-related insulin peptide.

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